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DMC reports in the 21st century: towards better tools for decision-making

Data Monitoring Committees (DMCs) have the important task to protect the safety of current and future patients during the conduct of a clinical study. Unfortunately, their work is often made difficult by voluminous DMC reports that are poorly structured and difficult to digest. In this article, we s...

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Autores principales: Vandemeulebroecke, Marc, Baillie, Mark, Mirshani, Ardalan, Lesaffre, Emmanuel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10120491/
https://www.ncbi.nlm.nih.gov/pubmed/37085883
http://dx.doi.org/10.1186/s13063-023-07290-4
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author Vandemeulebroecke, Marc
Baillie, Mark
Mirshani, Ardalan
Lesaffre, Emmanuel
author_facet Vandemeulebroecke, Marc
Baillie, Mark
Mirshani, Ardalan
Lesaffre, Emmanuel
author_sort Vandemeulebroecke, Marc
collection PubMed
description Data Monitoring Committees (DMCs) have the important task to protect the safety of current and future patients during the conduct of a clinical study. Unfortunately, their work is often made difficult by voluminous DMC reports that are poorly structured and difficult to digest. In this article, we suggest improved solutions. Starting from a principled approach and building upon previous proposals, we offer concrete and easily understood displays, including related computer code. While leveraging modern tools, the most important is that these displays support the DMC’s workflow in answering the relevant questions of interest. We hope that the adoption of these proposals can ease the task of DMCs, and importantly, lead to better decision-making for the benefit of patients. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07290-4.
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spelling pubmed-101204912023-04-23 DMC reports in the 21st century: towards better tools for decision-making Vandemeulebroecke, Marc Baillie, Mark Mirshani, Ardalan Lesaffre, Emmanuel Trials Methodology Data Monitoring Committees (DMCs) have the important task to protect the safety of current and future patients during the conduct of a clinical study. Unfortunately, their work is often made difficult by voluminous DMC reports that are poorly structured and difficult to digest. In this article, we suggest improved solutions. Starting from a principled approach and building upon previous proposals, we offer concrete and easily understood displays, including related computer code. While leveraging modern tools, the most important is that these displays support the DMC’s workflow in answering the relevant questions of interest. We hope that the adoption of these proposals can ease the task of DMCs, and importantly, lead to better decision-making for the benefit of patients. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07290-4. BioMed Central 2023-04-21 /pmc/articles/PMC10120491/ /pubmed/37085883 http://dx.doi.org/10.1186/s13063-023-07290-4 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Methodology
Vandemeulebroecke, Marc
Baillie, Mark
Mirshani, Ardalan
Lesaffre, Emmanuel
DMC reports in the 21st century: towards better tools for decision-making
title DMC reports in the 21st century: towards better tools for decision-making
title_full DMC reports in the 21st century: towards better tools for decision-making
title_fullStr DMC reports in the 21st century: towards better tools for decision-making
title_full_unstemmed DMC reports in the 21st century: towards better tools for decision-making
title_short DMC reports in the 21st century: towards better tools for decision-making
title_sort dmc reports in the 21st century: towards better tools for decision-making
topic Methodology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10120491/
https://www.ncbi.nlm.nih.gov/pubmed/37085883
http://dx.doi.org/10.1186/s13063-023-07290-4
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